Articulating osteotome with cement delivery channel

ABSTRACT

The present disclosure illustrates an osteotome for treating hard tissue. The osteotome embodiments described herein include a shaft with a working end configured to displace hard tissue and a lumen to deliver material through the shaft. The working end may create pathways by selectively transitioning from a linear to a non-linear configuration. The lumen may deliver material through the shaft while the working end is in a linear or a non-linear configuration allowing precise filling of the pathways.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/413,768, filed on Oct. 27, 2016 and titled, “Articulating Osteotomewith Cement Delivery Channel,” which is hereby incorporated by referencein its entirety.

TECHNICAL FIELD

The present disclosure relates generally systems and methods fortreating bone or hard tissue. More particularly, some embodiments relateto medical instruments and methods for creating a path or cavity invertebral bone and injecting bone cement to treat a vertebralcompression fracture.

BRIEF DESCRIPTION OF THE DRAWINGS

The written disclosure herein describes illustrative embodiments thatare non-limiting and non-exhaustive. Reference is made to certain ofsuch illustrative embodiments that are depicted in the figures, inwhich:

FIG. 1 is a perspective view of a medical device for treating hardtissue, according to one embodiment.

FIG. 2 is a perspective view of a tip of a medical device for treatinghard tissue, according to one embodiment.

FIG. 3 is a perspective view of an articulating portion of a medicaldevice for treating hard tissue, according to one embodiment.

FIG. 4 is a side cross sectional view of a medical device for treatinghard tissue, according to one embodiment.

FIG. 5 is a perspective view of an inner rod of a shaft with asemicylindrical portion, according to one embodiment.

FIG. 6 is a perspective view of a lumen with a stylet, according to oneembodiment.

FIG. 7 is a top cross sectional view of a medical device, according toone embodiment.

FIG. 8 illustrates a cross sectional view of an articulating portion ofa shaft in a linear configuration.

FIG. 9 illustrates the articulating portion of FIG. 8 in a first curvedconfiguration.

FIG. 10 illustrates the articulating portion of FIG. 8 in a secondcurved configuration.

FIG. 11 illustrates an introducer inserted into a vertebral body.

FIG. 12 illustrates an osteotome creating a pathway in the vertebralbody of FIG. 11.

FIG. 13 is a cross sectional view of bone cement being injected into thepathway of FIG. 12 through a lumen in the osteotome.

FIG. 14 is a perspective view of a medical device for treating hardtissue fluidly coupled to a bone cement injector, according to oneembodiment.

DETAILED DESCRIPTION

This disclosure provides methods and systems to treat hard tissue bycreating and filling cavities within a bone or other hard tissue. Amedical device for treating hard tissue may include a shaft with anarticulating portion, a handle configured to manipulate the articulatingportion, a side port that extends to an accessible portion of the shaft,and a lumen that is inserted in the side port. In one embodiment, aphysician may advance the articulating portion of the shaft into avertebral body. The physician may manipulate the handle to cause thearticulating portion to move from a linear configuration to a non-linearconfiguration. The change of the articulating portion's configurationmay displace tissue in the vertebral body creating a pathway. Thephysician may inject bone cement through the lumen while thearticulating portion is in a non-linear configuration allowing precisefilling of the pathway.

The shaft may include a conduit and a rod. The conduit may have a seriesof slots along a first side of a distal portion. The slots may allow thedistal portion to deflect thus forming an articulating distal portion ofthe conduit. The rod may include a semicylindrical portion that extendsthrough the conduit. The semicylindrical portion's shape may allow therod to flex when a force is applied and return to a linear position whenthe force is removed.

The rod may be coupled to the distal end of the conduit. In someembodiments, the rod and the conduit may be directly attached. Forexample, the rod and conduit may be welded together at the distal end.The weld may be along a distal tip of the rod and the conduit. In someembodiments, the weld may be disposed at an additional notch, hole orslot of the conduit, thereby increasing the welded surface area of theconduit and rod. In other words, the weld joint may be made around theperimeter of the notch hole or slot to attach the rod to the conduit.

The rod may extend through the conduit. The rod may extend along theslots on the first side of the conduit. The position of the slots in theconduit, and the relative position of the rod relative to the conduit,may limit the articulating distal portion to movement in one plane. Insome instances, when the rod is translated in the proximal direction(without displacing the conduit), the coupling and the positioningbetween the rod and the conduit may cause the rod and the conduit toflex at the articulating distal portion.

The shaft may also include a sharp tip located at an end of thearticulating distal portion of the conduit to penetrate hard tissue. Insome embodiments, the tip may be formed from the conduit and/or rod. Inanother embodiment, the sharp tip may be a separate part coupled to theconduit and/or rod. The articulating distal portion and tip may havesufficient strength to mechanically displace tissue within a vertebra ofa patient.

The handle may include an actuating portion coupled to a proximal end ofthe rod. The movement of the actuating portion may result in anassociated movement of the rod. For example, the actuating portion maycontrol the axial movement of the rod. In some embodiments, rotation ofthe actuating portion may result in a proximal movement of the rod.Thus, by rotating the an actuating portion a selected amount, thearticulating portion can be articulated to a selected degree, and thearticulating distal portion may selectively move between a linearconfiguration and an articulated configuration.

The handle may further include a force limiter. The force limiter maydisengage the actuating portion from the proximal end of the rod if atarget force is exerted on the actuating portion. The target force maybe near the breaking point of the articulating distal portion. The forcelimiter may protect the articulating distal portion from breaking.

Similarly, in some instances, the entire conduit and rod assembly may becoupled to the handle view a clutch or torque limiting assembly. Such anassembly may limit the amount of torque that can be transferred from thehandle to the conduit and rod assembly. This torque limiting assemblycan reduce breakage of the rod and/or conduit due to excessive forceapplied by the handle.

In some embodiments which include a torque limiter, cement or othersubstances may be displaceable along an injection path through thetorque limiter assembly by way of a shuttle component. The shuttlecomponent may be rotationally displaceable with respect to the conduitand may comprise opening around its circumference to create a fluid pathregardless of the rotational position of the shuttle with respect to theconduit.

A side port may be coupled to the handle. The side port may have aninsertion guide that extends to an accessible portion or working channelthe conduit. The working channel or accessible portion of the conduitmay be the portion not occupied by the semicylindrical portion of therod. A lumen may be inserted in the accessible portion.

An inserted lumen may extend through the conduit to an opening in thearticulating distal portion. The lumen may be a hollow semicylinder thatprovides a path for materials to pass through the conduit. The lumen caninclude a surface comprising a lubricious polymeric material. Forexample, the material can comprise any bio-compatible material havinglow frictional properties (e.g., TEFLON®, a polytetrafluroethylene(PTFE), FEP (Fluorinated ethylenepropylene), polyethylene, polyamide,ECTFE (Ethylenechlorotrifluoro-ethylene), ETFE, PVDF, polyvinyl chlorideand silicone). Similar to the rod, the lumen may be semicylindrical.Semicylindrical rod and the lumen may be positioned within the conduitto form a cylinder that fills the conduit.

A lumen port may be coupled to the lumen. The lumen port may include aclip. The clip may secure the lumen port to a side port with a clipholster. The semicylindrical shape of the rod and the lumen may preventthe lumen from being secured using a threaded connector due todifficulties with rotating a semicylindrical lumen within asemicylindrical accessible portion. The clip provides a method ofattachment that will not require the lumen to rotate. The lumen port mayselectively couple to a thermal energy delivery probe, a cement deliverycartridge, and a biopsy tool. The lumen may also be selectivelyremovable and replaceable. For example, if cement begins to block thelumen, a new lumen may replace the blocked lumen.

In some embodiments, a stylet may be selectively inserted in the lumen.The stylet may extend through the lumen for additional support to thearticulating distal portion. The stylet may be a flexible material thatfills the lumen. The stylet may be removed to allow the use ofadditional tools and cement.

The phrase “coupled to” is broad enough to refer to any suitablecoupling or other form of interaction between two or more entities,including mechanical, fluidic and thermal interaction. Thus, twocomponents may be coupled to each other even though they are not indirect contact with each other. The phrases “attached to” or “attacheddirectly to” refer to interaction between two or more entities which arein direct contact with each other and/or are separated from each otheronly by a fastener of any suitable variety (e.g., mounting hardware oran adhesive). The phrase “fluid communication” is used in its ordinarysense, and is broad enough to refer to arrangements in which a fluid(e.g., a gas or a liquid) can flow from one element to another elementwhen the elements are in fluid communication with each other.

The terms “proximal” and “distal” are opposite directional terms. Forexample, the distal end of a device or component is the end of thecomponent that is furthest from the physician during ordinary use. Theproximal end refers to the opposite end, or the end nearest thephysician during ordinary use.

The components of the embodiments as generally described and illustratedin the figures herein can be arranged and designed in a wide variety ofdifferent configurations. Thus, the following more detailed descriptionof various embodiments, as represented in the figures, is not intendedto limit the scope of the present disclosure, but is merelyrepresentative of various embodiments. While various aspects of theembodiments are presented in drawings, the drawings are not necessarilydrawn to scale unless specifically indicated.

FIG. 1 is a perspective view of a medical device 100 for treating hardtissue, according to one embodiment. In one embodiment, the medicaldevice 100 may be an osteotome configured for accessing the interior ofa vertebral body, creating a pathway in vertebral cancellous bone, andfilling the pathway with bone cement. The medical device 100 may includea shaft 102, a handle 104, a side port 106, and a lumen 108.

In use, a physician may introduce the shaft 102 through a pedicle of apatient's spine. The shaft may comprise a conduit 112 and asemicylindrical rod 114. The conduit 112 and rod 114 may be fabricatedof a suitable metal alloy, such as stainless steel or NiTi. The shaftmay be configured with an articulating portion 110. The articulatingportion 110 may deflect along one plane based on the coupling betweenthe conduit 112 and the semicylindrical rod 114. For example, as shownthe semicylindrical rod 114 may be contiguous with, and extend along, aseries of slots on the conduit 112. The series of slots may allow theconduit 112 to bend and the semicylindrical rod's shape may allow thesemicylindrical rod to bend. The articulating portion 110 may be locatedat the distal end of the shaft.

The articulating portion 110 may progressively actuate to curve aselected degree and/or rotate to create a curved pathway and cavity inthe vertebral body. A lumen 108 may be inserted through the side port106 and extend through the shaft 102 to provide a pathway for bonecement to pass. The articulating portion 110 may remain in a curvedstate while the bone cement may be injected directly into the cavity.

The handle 104 may be coupled to the proximal end of the shaft 102. Thehandle 104 may comprise a grip portion 116 and an actuator portion 118.The grip portion 116 may be coupled to the conduit 112. And the actuatorportion 118 may be operatively coupled to the semicylindrical rod 114.The shaft 102 may be coupled to the handle 104, to allow a physician todrive the shaft 102 into bone while contemporaneously actuating thearticulating portion 110 into an actuated or curved configuration. Thehandle 104 can be fabricated of a polymer, metal or any other material.In some embodiments, the material of the handle 104 may be suitable towithstand hammering or impact forces used to drive the assembly intobone (e.g., via use of a hammer or similar device on the handle 104).

The actuator portion 118 may be rotatable relative to the grip portion116. When the actuator portion 118 is turned, the articulating portion110 may associatively deflect. Some embodiments may have systems orelements for arresting the movement of the actuator portion 118 andthereby maintaining the deflection of the articulating portion 110. Forexample, in one embodiment, one or more plastic flex tabs of the gripportion may be configured to engage notches in the rotatable actuatorportion to provide tactile indication and temporary locking in a certaindegree of rotation.

The side port 106 may provide an aperture through the handle 104 into aportion of the shaft 102 not occupied by the semicylindrical rod, theaccessible portion or working channel 124. The lumen 108 may be insertedinto the side port 106 and extend through the shaft 102 along theworking channel 124. The lumen 108 may be secured to the side port 106with a clip 120. The lumen 108 may further include a threaded port 122to accept cement delivery devices, biopsy tools, and other medicalinstruments. In the embodiment illustrated in FIG. 1, a stylet 126 iscoupled to the lumen 108 via the threaded port 122,

FIG. 2 is a perspective view of a tip 200 of a medical device fortreating hard tissue, according to one embodiment. As shown, a conduit202 may encompass a rod 204 and a lumen 206. The embodiment of the tip200 shown in FIG. 2 is an example of a tip of the medical device 100 ofFIG. 1. In other words, various features of the tip 200 of FIG. 2 may beused in connection with the medical device 100 of FIG. 1 and vice versa.Disclosure recited in connection with FIG. 1 may not be repeated inconnection with FIG. 2 but such disclosure analogously applies to thetip 200 of FIG. 2, and vice versa. This pattern of disclosure applies toeach figure and embodiment recited in this application, features of eachembodiment may be understood as applying analogously to the otherembodiments.

The conduit may have a series of slots 208. The notches or slots in anyof the sleeves can comprise a uniform width along the length of theworking end or can comprise a varying width. Alternatively, the widthcan be selected in certain areas to effectuate a particular curvedprofile. In other variations, the width can increase or decrease alongthe working end to create a curve having a varying radius.

As shown, the rod 204 and the lumen 206 may both be semicylindrical.When paired together, their shape and sizing may form a cylinder thatfills the center of the conduit 202. The lumen may provide additionalsupport for the tip 200.

FIG. 3 is a bottom view of an articulating portion 300 of a medicaldevice for treating hard tissue, according to one embodiment. Theembodiment of the articulating portion 300 shown in FIG. 3 is an exampleof a tip of the medical device 100 of FIG. 1. In other words, variousfeatures of the articulating portion 300 of FIG. 2 may be used inconnection with the medical device 100 of FIG. 1 and vice versa.Disclosure recited in connection with FIG. 1 may not be repeated inconnection with FIG. 3 but such disclosure analogously applies to thearticulating portion 300 of FIG. 3, and vice versa.

A semicylindrical rod 302 may be attached to a conduit 304 in a varietyof ways. For example, the perimeter of the semicylindrical rod's arc maybe welded to the conduit 304 at the end. Other attachment spots may beused to secure the semicylindrical rod 302 to the conduit 304. Forinstance, the weld notch 306 shown provides a welding area to attach thesemicylindrical rod 302 to the conduit 304. In some embodiments multipleattachment means may be used to attach the conduit 304 to thesemicylindrical rod 302.

FIG. 4 is a cross sectional view of a medical device 400 for treatinghard tissue, according to one embodiment. As shown, the medical device400 may comprise a rod 402, a handle 406, a side port 408, a lumen 410,and a conduit 412. This cross sectional view of a medical device 400 isan example of the medical device 100 of FIG. 1. In other words, variousfeatures of the medical device 400 of FIG. 4 may be used in connectionwith the medical device 100 of FIG. 1 and vice versa. Disclosure recitedin connection with FIG. 1 may not be repeated in connection with FIG. 4but such disclosure analogously applies to the medical device 400 ofFIG. 4, and vice versa.

The rod 402 may comprise a cylindrical proximal end 414 and asemicylindrical distal end 416. The cylindrical proximal end 414 maymechanically couple to an actuator portion 404 of the handle 406. Themechanical coupling between the actuator portion 404 and the cylindricalproximal end 414 may translate a rotation of the actuator portion 404 toa force along the axis of the rod 402. The semicylindrical distal end416 may extend through the conduit 412 and occupy a bottom portion ofthe conduit. The semicylindrical distal end 416 may be flexible ascompared to the cylindrical proximal end 414 due to its shape.

The actuator portion 404 may displace the cylindrical proximal end 414.The displacement of the cylindrical proximal end 414 exerts a force onsemicylindrical distal end 416. The semicylindrical distal end 416 maybe attached to the conduit 412, causing the force on the semicylindricaldistal end 416 to bend the rod 402 and the conduit 706.

The lumen 410 may enter the conduit 412 via the side port 408. As shown,the side port 408 may be located on an upper portion of the handle 406.The side port 408 may include an aperture 418 that opens to an upperportion of the conduit 412. A physician may insert the lumen through theaperture 418. The lumen 410 may extend through the conduit 412 such thatthe side port has a first opening 420 at the distal end of the conduit412 and a second opening 422 at the side port 408.

In some embodiments, the lumen 410 may be secured to the side port witha clip 424. Due to the semicylindrical shapes of the rod 402 and thelumen 410, a standard threaded securing mechanism may not functionproperly. For example, in an embodiment where the lumen 410 does nothave room to rotate in the conduit 412, a standard threaded securingmechanism would not work. The clip 424 provides an alternative to securethe lumen the side port 408 with no need for the lumen 410 to rotate.The lumen may also include a threaded attachment point 426 toselectively couple to a stylet, a thermal energy delivery probe, acement delivery cartridge, or a biopsy tool.

FIG. 5 is a perspective view of an inner rod 500 of a shaft. The innerrod 500 of FIG. 5 is an example of the rod 114 in FIG. 1. Disclosurerecited in connection with FIG. 1 may not be repeated in connection withFIG. 5 but such disclosure analogously applies to the medical device 500of FIG. 5, and vice versa.

The inner rod may include a cylindrical portion 502 and asemicylindrical portion 504. The cylindrical portion 502 may provide arigid length of the inner rod 500 not intended to bend. Thesemicylindrical portion 504 may be configured via its shape to flex whena force is applied to it. As shown, the narrowing between thecylindrical portion 502 and a semicylindrical portion 504 may be rapid.In an alternative embodiment, the cylindrical portion 502 may graduallynarrow to a semicylindrical portion 504 to allow greater flexibility atsome points of the inner rod 500 than others.

FIG. 6 is a perspective view of a lumen 600 with a stylet 608, accordingto one embodiment. As shown, the lumen 600 may comprise a liner 602, aside port clip 604, and a threaded mating mechanism 606. The lumen 600of FIG. 6 is an example of the lumen 108 in FIG. 1. Disclosure recitedin connection with FIG. 1 may not be repeated in connection with FIG. 6but such disclosure analogously applies to the lumen 600 of FIG. 6, andvice versa.

The lumen 600 may provide additional support to a medical deviceadditional strength to treat hard tissue, and allow materials to passfrom one end to another end. A first opening 612 may allow materialssuch as bone cement to enter the lumen 600. A second opening 614 mayallow materials that enter into the lumen 600 through the first opening612 to exit. Alternatively material may be drawn from the second opening614 out the first opening 612 for procedures such as biopsies. The sideport clip 604 may secure the lumen 600 to a medical device, and thethreaded mating mechanism 606 may secure the lumen to additional toolssuch as a thermal energy delivery probe, a cement delivery cartridge, ora biopsy tool.

The stylet may include a cap 610 to secure the stylet 608 to the lumen600 via the threaded mating mechanism 606. The cap 610 may also preventforeign material from entering a vertebra through the lumen 600. Thestylet 608 may be supportive, such that when a stylet 608 is inserted inthe lumen 600, the resulting combination is more rigid than the lumen600 alone. This may provide a medical device additional strength totreat hard tissue. In some embodiments, a stylet 608 may be veryflexible for greater movement of the medical device. In an alternativeembodiment, the stylet 608 may be semi-rigid for extra support.

FIG. 7 is a top cross sectional view of a medical device 700, accordingto one embodiment. As shown, the medical device 700 may comprise amechanism for actuating 702 the rod 704 relative to the conduit 706.This top cross sectional view of a medical device 700 is an example ofthe medical device 100 of FIG. 1. In other words, various features ofthe medical device 700 of FIG. 7 may be used in connection with themedical device 100 of FIG. 1 and vice versa. This medical device 700 isalso an example of the medical device 400 of FIG. 4 with the crosssection taken along a different plane. Disclosure recited in connectionwith FIG. 1 may not be repeated in connection with FIG. 7 but suchdisclosure analogously applies to the medical device 700 of FIG. 7, andvice versa.

The conduit 706 may be statically attached to the handle 708. In someembodiments, the conduit 706 may be attached to the handle 708 via aweld, O-ring, molding, and/or clamp. The attachment may prevent theconduit 706 from moving or rotating relative to the handle 708. Theconduit 706 may also be attached to the rod 704 at or near a distal tip712,

The rod 704 may be attached to the mechanism for actuating 702 at aproximal end. The mechanism for actuating 702 may selectively translatethe rod 704 toward or away from the distal tip 712. A translation maycause the rod 704 to push or pull at the attachment point between theconduit 706 and the rod 704. Because the conduit 706 is static relativeto the handle, the pushing or pulling may cause the rod 704 and theconduit 706 to deflect.

The mechanism for actuating 702 may be coupled to an actuator portion716 of a handle. The mechanism for actuating 702 may include a threadactuator 718 and a clam shell 720 with threaded mating bearing 722. Thethread actuator 718 may couple to the actuator portion, such that when aphysician rotates the actuator portion 716, the thread actuator 718 alsorotates. The clam shell 720 may attach to the rod 704 and engage thethread actuator 718 with the threaded mating bearing 722. As the threadactuator 718 rotates, the threaded mating bearing 722 may slide alongthe threads of the thread actuator 718 preventing the clam shell 720from rotating while translating the clam shell toward or away from thedistal tip 712.

The mechanism for actuating 702 may displace the proximal end of the rod704. The displacement of the proximal end of the rod 704 exerts a forceon the distal end of the rod 704. Because the distal end of the rod 704is attached to the conduit 706, the force on the distal end of the rod704 causes the rod 704 and the conduit 706 to flex.

FIGS. 8-10 illustrate cross sectional views of an articulating portion800 of a shaft in a linear configuration and a first and a second curvedconfiguration. The articulating portion 800 may be analogous to thearticulating portion 110 of FIG. 1. The articulating portion 110 of FIG.1 may operate in analogously to the articulation portion 800 of FIG. 8,and vice versa.

The ability of the articulating portion 800 to curve is due to thenotches 804 in the conduit 806 and the shape of the rod 802. The rod'ssemicylindrical shape causes it to have a greater flexibility than ifthe rod was cylindrical to permit the rod 802 to bend. The direction thearticulating portion 800 may be limited by the location of the notches804 in conduit 806. For instance, the articulating portion 800 may onlybend along the plane of the notches 804. The articulating portion 800 isrigid in any other direction. The curvature of any articulatedconfiguration is controlled by the spacing of the notches as well as thedistance between each notch peak.

FIG. 8 illustrates the articulating portion 800 in a linearconfiguration. FIG. 9 illustrates the articulating portion 800 in afirst curved configuration. The first curved configuration is causedwhen the rod 802 pushes the conduit 806 in the distal direction. Forinstance, the rod 802 may be welded near the tip to the conduit 806.Because the rod is attached to the conduit, a force pushing the rod 802while the conduit 806 is held stationary would cause the rod 802 to pushthe tip of the conduit 806 causing it to flex to allow the rod to movein the distal direction. FIG. 10 illustrates the articulating portion800 in a second curved configuration. The second curved configuration iscaused when the rod 802 pulls the conduit 806 in the proximal direction.For instance, the rod 802 may be welded near the tip to the conduit 806.Because the rod is attached to the conduit, a force pulling the rod 802while the conduit 806 is held stationary would cause the rod 802 to pullthe tip of the conduit 806 causing it to flex to allow the rod to movein the proximal direction.

FIGS. 11-13 are cross sectional views of an osteotome in use, accordingto one exemplary method. The method may include obtaining a medicaldevice having a sharp tip configured for penetration into vertebralbone, the medical device comprising, advancing the working end into avertebral body. Once in the vertebral body, the physician may cause theworking end to move from a linear configuration to a non-linear tocreate a pathway in the vertebral body. The physician may further injecta fluid through the lumen while the working end is in a non-linearconfiguration to fill the pathway with the fluid in a precise pattern.

FIG. 11 illustrates an introducer 1100 being inserted into a vertebralbody 1106. A physician taps or otherwise drives an introducer 1100 andsleeve 1105 into a vertebral body 1106 typically until the introducertip 1108 is within the anterior ⅓ of the vertebral body toward corticalbone 1110.

Thereafter, the introducer 1100 is removed and the sleeve 1105 is movedproximally (FIG. 12). As can be seen in FIG. 12, the tool or osteotome1200 is inserted through the introducer sleeve 1105 and articulated. Theosteotome 1200 may be the medical device 100 in FIG. 1. The working end1210 can be articulated intermittently while applying driving forces andoptionally rotational forces to a handle of the osteotome to advance theworking end through the cancellous bone 1212 to create path or cavity1215. The tool is then tapped to further drive the working end 1210 to,toward or past the midline of the vertebra. The physician canalternatively articulate the working end 1210, and drive and rotate theworking end further until imaging shows that the working end 1210 hascreated a cavity 1215 of an optimal configuration.

Thereafter, as depicted in FIG. 13, the physician may inject bone cement1322 through a lumen 1324 while the working end 1210 is in a non-linearconfiguration. The capability of injecting bone cement 1322 while theworking end 1210 in a non-linear configuration provides the physicianwith precise control over how the path or cavity is filled.

FIG. 14 is a perspective view of a medical device 1400 for treating hardtissue fluidly coupled to a bone cement injector 1402, according to oneembodiment. As shown, the injector 1402 may couple to the medical device1400 by engaging the threaded mating mechanism 1406 of the lumen 1408. Aphysician may use the injector 1402 to push cement through the lumen1408. The cement may travel through the medical device 1400 and exit adistal tip 1410.

Any methods disclosed herein include one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.Moreover, sub-routines or only a portion of a method described hereinmay be a separate method within the scope of this disclosure. Statedotherwise, some methods may include only a portion of the stepsdescribed in a more detailed method.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure, orcharacteristic described in connection with that embodiment is includedin at least one embodiment. Thus, the quoted phrases, or variationsthereof, as recited throughout this specification are not necessarilyall referring to the same embodiment.

Similarly, it should be appreciated by one of skill in the art with thebenefit of this disclosure that in the above description of embodiments,various features are sometimes grouped together in a single embodiment,figure, or description thereof for the purpose of streamlining thedisclosure. This method of disclosure, however, is not to be interpretedas reflecting an intention that any claim requires more features thanthose expressly recited in that claim. Rather, as the following claimsreflect, inventive aspects lie in a combination of fewer than allfeatures of any single foregoing disclosed embodiment. Thus, the claimsfollowing this Detailed Description are hereby expressly incorporatedinto this Detailed Description, with each claim standing on its own as aseparate embodiment. This disclosure includes all permutations of theindependent claims with their dependent claims.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. It will be apparent to those ofskill in the art, having the benefit of this disclosure, that changesmay be made to the details of the above-described embodiments withoutdeparting from the underlying principles of the present disclosure.

We claim:
 1. A medical device for treating hard tissue, comprising: aconduit having a series of slots along a first side of an articulatingdistal portion of the conduit; a rod extending through the conduit, therod including a flexible portion; a handle including an actuatingportion coupled to a proximal end of the rod, wherein movement of theactuating portion results in an associated movement of the rod and theconduit to selectively move the articulating distal portion between alinear configuration and an articulated configuration; and a side portcoupled to the handle with an insertion guide that extends to anaccessible portion of the conduit extending along the conduit to adistal end of the conduit; further comprising a lumen inserted in theinsertion guide and extending through the conduit, wherein the lumen issemicylindrical, and wherein the semicylindrical flexible portion of therod and the lumen are positioned within the conduit to form a cylinderthat fills the conduit.
 2. The medical device of claim 1, furthercomprising a lumen port with a clip coupled to the lumen, and whereinthe side port includes a clip holster to secure the lumen port to theside port.
 3. The medical device of claim 2, wherein the lumen port isconfigured to selectively couple to a thermal energy delivery probe, acement delivery cartridge, and a biopsy tool.
 4. The medical device ofclaim 2, wherein the lumen is selectively removable and replaceable. 5.The medical device of claim 1, wherein the conduit includes a notch onthe first side of the distal portion, wherein the conduit and rod areattached by a weld joint around a perimeter of the notch.
 6. The medicaldevice of claim 1, wherein the articulating distal portion hassufficient strength to mechanically displace tissue within a vertebra ofa patient.
 7. The medical device of claim 1, wherein the articulatingdistal portion is configured to transition from the linear configurationto the articulated configuration in only a single plane.
 8. The medicaldevice of claim 2, further comprising a stylet selectively inserted inthe lumen and extending through the lumen for additional support to thearticulating distal portion.
 9. The medical device of claim 1, whereinthe handle further includes a force limiter that disengages theactuating portion from the proximal end of the rod when a target forceis exerted on the actuating portion.
 10. The medical device of claim 1,wherein the flexible portion comprises a semicylindrical portion coupledto the articulating distal portion of the conduit and contiguous withthe first side of the conduit.
 11. The medical device of claim 1,further comprising a sharp tip located at an end of the articulatingdistal portion of the conduit to penetrate hard tissue.
 12. A medicaldevice for treating hard tissue within a vertebra of a patient, themedical device comprising: a shaft having an articulating portion, theshaft comprising: a hollow conduit with a series of slots along a firstside to permit deflection, and a semicylindrical rod extending throughthe hollow conduit and contiguous with the first side of the hollowconduit, wherein the hollow conduit and semicylindrical rod are coupledat a distal end of the articulating portion such that a force appliedalong an axis of the semicylindrical rod translates to a deflection inthe articulating portion to move reversibly between a linearconfiguration and an articulated configuration, where the series ofslots and the semicylindrical rod limit movement between the linearconfiguration and the articulated configuration to a single plane; aside port with a clip holster that extends to an accessible portion ofthe shaft extending along the hollow conduit to a distal end of theconduit; and a lumen having a clip to selectively secure the lumen to aninsertion guide, the lumen extending through the hollow conduit withopenings at both ends to permit movement of material through the shaftwithout being in contact with the shaft.
 13. The medical device of claim12, wherein the articulating portion has sufficient strength tomechanically displace tissue within a vertebra of a patient.
 14. Themedical device of claim 12, wherein the shaft further comprises apointed distal end that is configured to penetrate bone within avertebra of a patient.
 15. The medical device of claim 12, wherein thelumen comprises a threaded interface to selectively couple to a thermalenergy delivery probe, a cement delivery cartridge, and a biopsy tool.16. The medical device of claim 12, further comprising a styletselectively inserted in the lumen and extending through the lumen foradditional support to the articulating portion.
 17. The medical deviceof claim 12, further comprising a handle including an actuating portioncoupled to a proximal end of the rod, wherein manipulation of theactuating portion causes deflection of the articulating portion.
 18. Themedical device of claim 17, wherein the handle further includes a forcelimiter that disengages the actuating portion from the proximal end ofthe rod when a target force is exerted on the actuating portion.
 19. Themedical device of claim 12, wherein the lumen is selectively removableand replaceable.
 20. The medical device of claim 12, further comprisinga source of a bone cement material that is fluidly coupled to the lumenfor the bone cement material to pass through the lumen to exit at thedistal end of the articulating portion.